Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00702676
First received: June 19, 2008
Last updated: July 15, 2009
Last verified: July 2009
  Purpose

This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.


Condition Intervention Phase
Healthy Volunteers
Drug: Quetiapine Fumarate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Double-dummy, Randomized, Crossover Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) During Initial Dose Escalation in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) 1 hour post dose at Day 1 [ Time Frame: 1 hour after dose administration at the first dosing day (i.e. Day 1) of each period ] [ Designated as safety issue: No ]
  • Area under the VAS-time curve [ Time Frame: Calculated daily from the 13 assessments for 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic relationship between maximum VAS and PK concentration [ Time Frame: On last day of period (Day 5) ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: July 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Quetiapine Fumarate Immediate Release
Drug: Quetiapine Fumarate
Tablet, Oral, once daily
Other Name: Seroquel IR
Experimental: 2
Quetiapine Fumarate Extended Release
Drug: Quetiapine Fumarate
Tablet, Oral, once daily
Other Name: Seroquel XR

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Weight of at least 50 kg

Exclusion Criteria:

  • A history or presence of neurological, hematological, psychiatric, gastrointestinal, hepatic, pulmonary, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  • Positive test results for alcohol or drugs of abuse
  • Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702676

Locations
United States, Maryland
Research Site
Baltimore, Maryland, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Datto, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans A Eriksson, MD, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00702676     History of Changes
Other Study ID Numbers: D1443C00033
Study First Received: June 19, 2008
Last Updated: July 15, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by AstraZeneca:
Healthy Volunteers

Additional relevant MeSH terms:
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014